Setting the Record Straight on Usability & Human Factors

What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about human factors and usability—two terms used synonymously despite subtle differences—to help you better understand their similarities and differences, how each function, and when each should be applied.

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Some highlights of this episode include:

• Mike defines usability or human factors as the user’s ability to use the device in a way that it is intended to be used to get the result it’s intended to get.
• Jon understands how product development engineers forget that they designed a product based on how they think it should operate, function, and be used.
• Unfortunately, there are few opportunities for engineers to actually test, use, or implant a product that they developed and designed on actual end users, like cadavers or live animals.
• The user population has expanded beyond a trained healthcare professional. From a human factors perspective, it doesn’t always make sense or make it easier or complicated for some people to use medical devices.
• Current FDA guidances that focus on general usability/human factors for medical devices are inadequate. FDA does not differentiate devices that should be used by a trained healthcare professional versus a patient or lay person. 
• Usability is important in virtually all medical devices, but there are some exceptions. However, usability is even more important when medical devices are being used by non-trained medical professionals.
• FDA now requires usability testing for medical devices because of issues with infusion pumps. However, usability testing should be considered based on risk. Is usability testing needed to put on a BAND-AID® or spit into a tube?
• There are two types of usability testing:
  • Formative: this type of usability testing happens prior to design freeze during the development process.
  • Summative: this type of usability testing occurs after the point of design freeze to ensure that the product can be used as intended.

Links:

FDA - Applying Human Factors and Usability Engineering to Medical Devices

FDA - List of Highest Priority Medical Devices for Human Factors Review

FDA - Premarket Notification 510(k)

FDA - In Vitro Diagnostics Regulation (IVDR)

The Global Medical Device Podcast, Episode 223: Understanding FDA's New Intended Use Rule and its Implications

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from this episode: 

“Usability or human factors is the user’s ability to use the device in a way that it’s intended to be used to get the result that it’s intended to get.” Mike Drues

“Those who are designing the product are stuck and convinced that they know the way the product should be used.” Jon Speer

“The user population has expanded beyond a trained healthcare professional.” Jon Speer

“Usability is important in virtually all medical devices across the board. Not all, there are some exceptions, but virtually all.” Mike Drues

Transcription:

Announcer: Welcome to The Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts in companies.

Jon Speer: On this episode of The Global Medical Device Podcast, I had a wicked good time with Mike Drues from Vascular Sciences and we talked quite a bit about human factors, usability, and some of the, I guess, nuances around that. Or some of the head trash and maybe some of the myths around what usability and human factors is and is not and when it applies and that sort of thing. So I hope you enjoy this episode of The Global Medical Device Podcast. Hello and welcome to The Global Medical Device Podcast, this is your host and founder at Greenlight Guru, Jon Speer. Joining me today on location is Mike Drues from Vascular Sciences. Mike, welcome.

Mike Drues: Thank you, John, always a pleasure to speak with you and your audience.

Jon Speer: Yeah, I'm waiting for the Boston accent. Although I've never heard it from you before, but since you're back in your stomping grounds, maybe get a little bit of Boston slang coming out. I know a word I'm looking for, and I bet you say it before this podcast is over, so we'll wait and see. But anyway, we're not going to talk about slang or language per se, actually something-

Mike Drues: So if it would help, John, if I can park the car, would that make you feel better?

Jon Speer: You'll say the word. I know you're going to say it, so stay tuned folks. And if he doesn't, I'll say it for him at the end. But no, Mike, you and I have talked about this topic before, but it's one that keeps coming up because I think there's, I don't know, I guess confusion or... Well, we'll just leave it at that, confusion. And that topic is human factors or, I guess said maybe a slightly different way, usability. And maybe that's the first place to start, human factors, usability. What is it? Are they the same? Are they different? So I'll let you dive in there.

Mike Drues: Yeah. Great question, John, and good place to start. And as always, thanks for the opportunity to talk with you and your audience about this very important topic. Because you're right, lots of people come to me with questions about usability or human factors or a third term that it goes by is ergonomics. I think, for all practical purposes, we can use those three different terms or phrases synonymously; usability, human factors, ergonomics. Yes, there are some subtle differences. As a matter of fact, just the other day, I was talking to one of my friends, who happens to be a subject matter expert in this area, and he was pointing out some of the differences between those three. But for most of us who are not necessarily SMEs in this particular area, I do a lot of work in this space, I think we can think about those being synonymous or, to use a regulatory pun, John, being substantially equivalent to one another. More importantly, what do they mean? So my working connotation of usability or human factors is the user's ability to use the device in a way that it's intended to be used to get the result that it's intended to get. And one of the things I'm sure we'll get into further here, John, is the relationship between usability and labeling. And specifically, the intended use of the indications for use. And if you want to really kick the discussion up a few notches, John, talk about usability, not for on- label uses of the product, but what are the usability concerns and potential ramifications when the product is used awfully. That is, in a way that is not consistent or inconsistent with what's on the product label. So I don't want to jump the gun, John, we're starting out at the beginning. What is usability? That's my very, very simple definition. Do you see it any differently, John?

Jon Speer: I don't know that I see it differently. I guess maybe add a bit more context to this. I mean, maybe I'm jumping the gun a little bit, but I remember early days as a product development engineer, to me as the designer of the product is was like, of course one would do this and this, and here's how it works, and that sort of thing. But I think sometimes product development engineers forget that they have a unique context because they designed the product according to what they thought, how it should operate, function, how the person would use it, and so on and so forth. And sometimes engineers, I can say this because I am one, sometimes we're stubborn and we feel like we have the right answer, regardless of what others around us may believe or not believe. But I think that's maybe part of the issue on this topic is that, those who are designing the product are stuck and convinced that they know the way the product should be.

Mike Drues: Actually I think, John, that's a good point. And let me take that just a little bit further. One of the ironies, if you will, that I've found early in my career... 30 years ago working as a biomedical engineer, and specifically as an R& D engineer is, medical device design, in many cases, it's very unique in the engineering sense. In that the products that most medical device designers are designing and developing, they are not products that that engineer can use themself. In other words, if you, as an engineer, were designing a car, you can always get into the car and test drive it yourself and see how it responds and so on. But if you're designing, for example, a coronary stent. I don't know about you, John, but most engineers are not able to put that stent into a person. In other words, use that device the way that it's intended to be used. And so it's kind of like you're relying on other people, in this case surgeons, to tell you how your device is functioning and how the usability sits. So that's a big challenge. Now today, of course, we do have a growing number of devices that are intended to be used by a non- clinician, a non- physician or surgeon, maybe even by the patient themselves. And in those cases, the engineer might be able to test it themselves. But in a lot of cases, they can't do that. And so, from a usability perspective, I think, John, that does present a number of significant and unique challenges.

Jon Speer: Yeah, for sure. And I want to come back and maybe explore that last little bit that you shared here in a moment. I think opening the user base up to the general population, I think that has its own challenges, but we're going to come back to that. But I remember, to your point, I remember... I mean, yes, most engineers have never gone in, actually placed a device that they design, especially if the user of that product is a clinician, physician, what have you. Sometimes I think we have opportunities, and hopefully some of those opportunities become light bulb moments, and I remember an opportunity that I had a few years into my career. I was designing an emergency cricothyrotomy device, basically an emergency airway that was going to go right into the cricothyroid membrane. And I had an opportunity to do some cadaveric testing on the thing. And it was myself and another colleague basically left alone in a cadaver lab, which I don't know if those things fly these days, but nonetheless, it was an invaluable-

Mike Drues: It's not like you could hurt those people.

Jon Speer: Well, that's true, yeah. But it was an invaluable experience because even though it was a product I designed, I immediately picked up on some flaws and, to go a little bit deeper on this, this particular device had a flexible balloon. A silicone sleeve- type balloon on it. Actually, I think it was polyeurethene, but nonetheless, one of the steps involved using a little bit of a razor blade to make a skin nick as you're placing this. And I immediately realized, holy cow, razor blades and balloons, not a good combination. Because that balloon is supposed to inflate and seal the airway, but you've nicked it in the process of placing it, that's a problem. So that was a good experience for me to go through to learn that, but you're right, most people don't have that opportunity.

Mike Drues: And actually, John, let me take your example and share with you a substantially equivalent example from my world, from many, many years ago. As some in our audience probably know, I started out my career about 30 years ago as an R& D engineer, before transitioning to the dark side, in my case, not marketing but regulatory. I started out as an R& D engineer and I designed a lot of devices, including coronary stents. And one of the things that I found fascinating was how few people who designed devices like coronary stents, for example, have ever held a beating heart in their hand. And one of the things that I consider myself very, very fortunate as a biomedical engineer, I went to school many years ago at Iowa state. And I had an opportunity to do a lot of surgery, not on cadavers, but on live animals. Where you could literally, not just learn the anatomy, but the physiology and the pathophysiology. So how does somebody design a stent who has never held a beating heart in their hand? To use my car metaphor, John, it's like asking an engineer to design a car who has never driven a car before. And I don't know what troubles me more, the fact that this happened so frequently or the fact that so few people even stop and ask that question. Hey, does that even make sense? But anyway, that's a topic, perhaps, of a different discussion, John.

Jon Speer: Yeah. Yeah. And I want to come back to that comment that you made earlier about, a lot of devices these days... Or essentially, the user population is expanded beyond a trained healthcare professional. I mean, it could be a layperson. And how do you feel that that does from a human factors perspective? Okay, well, one perspective, me as engineer could be that user. So I might have that, now, context. But then again, so can my grandmother. Or my child. Does that make things easier or more complicated?

Mike Drues: Yeah. Great question, John. In my not so humble opinion, this is one of the areas where the guidance or the regulation from FDA is woefully inadequate. Inadequate. What I mean by that is, in the almost a dozen guidances now that FDA has put out in the general area of usability or human factors or whatever you want to call it, they really do not differentiate between devices that are intended to be used by a trained medical professional. In other words, somebody who has graduated from medical school or dental school or nursing school or something like that versus a layperson. And as I think, perhaps, as you and I have talked a little bit about in the past, John, I think that usability is... Well, usability is important in virtually all medical devices across the board. Not all, there are some exceptions, but virtually all. But I think that, for devices that are intended to be used by a non- trained medical professional, in other words, somebody that has not going to med school, usability is even more important than for a trained medical professional. So this is, you and I have talked about many times, John, this tick- box mentality that so many people in our industry seem to suffer from. Where we just meet the regulatory requirements. Well, I would just offer to our audience that if you are working on a medical to device that's intended to be used, your intended user, not the patient, but the user of the device is a non- trained medical professional, then maybe just meeting those FDA requirements might not be enough. What do you think of that, John?

Jon Speer: Totally. I mean, well confession, there's so many people that seem to resist human factors. And I have some speculation as to why. My confession is that many, many years ago I resisted it because I don't know that I appreciated or understood the benefit. This seemed like another thing that was being asked of me that was duplicative of things that I was already doing. I designed controls. I felt like, back in the day when I started my career, back in the late 90s, right when the design control regulations became a thing in the US, that that was my job as an engineer. We didn't need a separate discipline for human factors and a separate discipline for risk, but low and behold, as time progressed, now there's all these different disciplines. I'm like, whoa, time out. Why am I an engineer if I'm not thinking about risk? If I'm not thinking about the human interactions? Why do I need to create all these other different files and records and documents? Why wouldn't I just do that in a design control context?

Mike Drues: Actually, that's a great point, John. And let's peel back the onion on that a little bit further. Not to put you on the spot here, but a lot of people don't realize that, although today usability testing for medical devices has become the rule rather than the exception, not long ago... And what I'm talking about here is about seven or eight or 10 years ago, usability testing of medical devices was very much the exception, not the rule. In other words, prior to about eight or so years ago, there was no expectation by FDA for usability testing for virtually all medical devices. Today, there is. So do you recall, John, what the precipitating event was that basically led to usability testing now being expected for most medical devices across the board?

Jon Speer: Man, that was a twist. I didn't see that question coming.

Mike Drues: Sorry, I didn't mean to crosstalk.

Jon Speer: No, that's Okay. The short answer is, no, I don't recall the precipitating event.

Mike Drues: Well, and by the way, I have asked some folks who claim to be experts in usability testing, why is usability testing required today? What was the precipitating event? Some of them give me the exact same response that you did, I don't know. Which begs the question to me, so why do you call yourself an expert in this area? Well, the short answer, John, is the infusion pump fiasco, as I call it, from almost a decade ago. And we could have a discussion just simply on this, where there were about 80 infusion pump from a wide variety of manufacturers that all experienced problems, usability related problems. And this is the precipitating event, if you will, that led to usability testing across the board. Kind of like the silicon breast implant fiasco, leading to bio- com testing, and the reprocessing fiasco, the people that were killed because of the reprocessing problems of the duodenoscopes at UCLA, and so on. There are certai watershed moments, if you will, or milestone events that precipitate these, that was the one that happened here. And at that time, I was one of a few people that were invited to come into the FDA to talk about this. Because at that time, as you may remember, John, there were some people, actually both in the FDA as well as in industry, that were advocating clinical trials for infusion pumps. And I basically walked into the agency and I said," That's nuts. That's absolutely nuts." I said," There's nothing that you can test an infusion pump for in the clinic trial that you can't test for on the bench top."

Jon Speer: Absolutely.

Mike Drues: So the pendulum swings from one extreme to the other, but that's basically where all this is stemmed from. Now, coming back to your previous point, John, don't miss my message. I'm not suggesting that companies should not do usability testing. On the contrary, I think from a biomedical engineering perspective, it would be almost unconscionable for a company to release product without doing some kind of usability testing. The question is, and I think this cuts to your point, John, why should we need the FDA or anybody, the police, to tell us to do something that we should, as medical device professionals, if we are going to consider ourselves a medical device professional. That comes with the expectation of expertise and responsibility. We should know to do those things ourselves. And unfortunately, John, I didn't fall off the turnip truck yesterday. Regrettably, there are companies out there, and the people in them, that will not do something unless you say to them," You must do it."

Jon Speer: I mean, as you were speaking there, I was reminded of one of our first interactions. And the topic of our first interaction was design verification versus design validation. And design verification, you described it so eloquently that I borrowed your terminology sense. But design verification is, did we design the product correctly? Design validation, did we design the correct product? Isn't that, in essence, what human factors is all about? And usability all about? I mean, I guess we can leave that as a hanging question for a moment.

Mike Drues: Well, to be clear, John, I'm not sure I can take original credit for that, I'm sure I probably stole it from somebody else. But they say if you're going to steal, steal from the best. So I'm flattered that you're referencing that. Actually, maybe John, this brings us to one of the next topics to talk about, and that is, should we require usability testing for all medical devices across the board? FDA, as I mentioned, has put a out nearly a dozen guidances in this area. One of them that FDA put out, just in 2016, is titled The List of Highest Priority Medical Devices for Human Factors Review. And I've actually gotten questions from some of my customers, John, I would love to hear your thoughts on this. Basically they say," Well, if my device is not in this guidance..." By the way, it's a very short guidance, it's only six pages." If my device is not on this guidance, does that mean that I do not have to do human factors testing on it?" And I warned FDA when they put out this guidance, because as you know, John, I work as a consultant for the FDA. I said," There are going to be people who misinterpret this. If it's not on this high priority list, that means I don't have to do it." But do you think, John, that we should require usability testing for all medical devices? Because that would be a very, very easy requirement to create and it would just become a tick- box on the form. But is that the kind of regulation that you think we should have?

Jon Speer: Well, I'm not an advocate of just creating another checkbox on a form that people are going to blindly just do something because, well the form says I have to do it, and FDA is mandating it, so therefore I must do it. Again, I just think it goes back to my role and responsibility as a medical device professional. I mean personally my north star, my guiding principle is, I want to make sure the things that I'm involved with, the things that I work on, the things that I do, have a positive impact on the quality of life. If I'm designing a medical device, then gosh darn it, the damn thing should work. And it should work as expected. I mean, all the time. I mean, every time is what I'm striving for because a failure is not... Well, bad things can happen. And some devices are complicated, and I feel I'm a pretty smart person, I know people smarter than me, but I feel like I'm pretty smart. And just because I know or can figure something out if it's not intuitive or obvious to others, and they're the ones that are going to be using product, then I think that's a problem. So that was a long way for me to say, yeah, I think every medical device has to factor in usability. It has to incorporate or address the human interactions of that product. I think that's an absolute.

Mike Drues: Well, that's interesting, John, because I have a slightly different perspective on this. I do not think that regulation, including usability requirements, should apply across the board. In other words, I do not think that, regardless of what type of medical device you're developing, every single device should undergo usability testing. Because keep in mind, John, that the medical device world-

Jon Speer: I would agree with that statement. I know that might seem like contradiction, but I would agree with that statement. Absolutely.

Mike Drues: Okay, okay. So maybe you and I are singing the same song, but just in a slightly different key. So let me just continue a little bit further and then I would love to hear your thoughts. So remember, the medical device universe is a very broad universe. On one end, we have things like bandaids and wheelchairs and on the other end of the spectrum, we have things like totally implantable artificial hearts. And clearly, there are lots of examples of medical devices and medical device technology where usability is very important. And those areas would include things like, where the safety and the efficacy of the device is a very strong function of the skill level of the user. In other words, some of my favorite examples would be technologies like endoscopy, like laparoscopy, like catheter- based technologies. Again, simple example, I can take one catheter and put it in one physician's hands and get wonderful results. I can take exactly the same catheter and put it in another physician's hands and get abysmal results. And so, in those kinds of areas, usability, to me as an engineer, is a no- brainer. On the other hand, there are other kinds of medical devices. Let's say for example, an invitro diagnostic, and IVD, where literally you take a sample from a patient, you stick it into a machine, you push a button, and you're done. So from a usability perspective, yeah, there could be some issues when it comes to graphical user interfaces and so on. But for the most part, usability is not a real concern. So I think that we need to take a more personalized approach. It should be up to us as manufacturers to decide if usability testing is necessary for our particular device. And if so, how much, to what degree? And then we take it to the FDA. Oftentimes it's a pre sub meeting, John, and we sell it to them so that we don't have to speak in generalities or platitudes. Let me just give you two examples. These are devices that I'm working on right now, so I have to be a little bit careful what I say here, to show the inconsistencies in the world in which we live. The first device, very, very simple device. It's basically a tube that you spit in. It's a saliva collection device, that's it. In my opinion, the FDA is being tremendously, overly burdensome in requiring a ton of usability data on this particular device. I mean, literally, you spit in a tube and you're done. And they're asking the company to jump through a whole bunch of hoops, and of course, I'm encouraging pushback because I do think this is overly burdensome. But like many companies, John, they don't want to rock the boat and blah, blah, blah. On one hand, we've got that example. On the other hand, at the exact same time, and the irony that these two things are happening to me at the same time, John is just stunning. I have another device that is... Going to have to be careful what I say here, this is a device that was originally brought onto the market as a 510K. It's a device that's indicated for intraocular injection, so we inject something into the eye, and this particular device, the original version of the device, was brought to the market before I started working with this particular company. And I asked them, among other things," What kind of usability testing did you do?" And they said," None." And I said," And you got a 510K, to stick something into somebody's eye, without any usability testing?" Yeah. I said," Well, consider yourself to be very, very lucky." Lucky in a regulatory sense, perhaps, because when we go back to the FDA for next generations of this device, I think the company's luck is going to run out. So on one hand, we have this very, very simple saliva collection device, spit in a tube, and we got to do ton of usability testing. On the other hand, we've got this device that we have to stick something into somebody's eye that has required no usability testing, John. I don't know, I'm not always brightest bulb on the tree, but I'm not sure I can connect the dots between those two things.

Jon Speer: Yeah. I'm definitely not going to be able to connect those that either. And I guess, from my perspective, I might not have been clear what I was trying to convey earlier. My opinion is, my job as a medical device professional, is I need to address human factors and usability for every single product that I design and develop. The depth and detail in which I do that needs to be commensurate with the risk and the human interactions of that product. And I think this is illustrative of your example, the ocular injection and the spit tube, those are completely different risk paradigms. And what I need to do, from a human factors perspective, should be commensurate with that risk and the user and so on and so forth.

Mike Drues: Well, to your point, John, let me modify what I just said. Because I appreciate your clarification and allow me the opportunity to just to be crystal clear as well. Based on what you just said, I'll modify my recommendation. I would suggest that all companies, as part of their product development checklist, if you will, you should always consider usablity... I'm saying that you should always do usability testing, I'm saying you should always consider it. In other words, it should be one of the tick boxes on your form, so to speak. But in some cases, after you consider it, after you do the evaluation, including the risk evaluation, then you make the decision, do we need to do usability testing? Please don't do it just because you think it's required or not. Because that, in my opinion, is not a good excuse. But consider whether or not usability testing makes sense for you. And if it does, how much usability testing and so on. Even the spit in the tube example that I shared a moment ago, maybe a small amount of usability might be prudent, but the amount that FDA is asking the company to do, in my opinion is totally whackadoodle. So anyway, so I would modify my... Like I said a moment ago, based on what you just said, we should always consider it. But whether we do it or not, that's up to us. And then as I said earlier, John, because this is an important point, you should always take this to the FDA and sell it to them. Ideally in the form of a pre- submission meeting, not in your final submission.

Jon Speer: Yeah. I want to come back to that, but I think it's important to clarify for folks when we say usability testing. That is a term that has, I guess some formality to it, I don't know if that's the right way to describe it. It has or connotation or meaning that there's some sort of protocol, there's maybe a summative or formative portions of that. So when we say usability testing, that's what we're referring to, is that the lexicon that's become part of the human factors usability dictionary.

Mike Drues: Good question, John. So let's dig into that a tiny bit further. So when we you talk about usability testing, you're right, we shouldn't be overly general or stereotypical here. There's typically two different types of usability testing, the formative followed by the summative. In a nutshell, and this is a topic we could have an entire discussion on, John, but in a nutshell, formative usability testing is testing that happens prior to design freeze, during the development process. And the objective, the purpose of formative testing, is to provide feedback to the designers. To make sure that the device can be used in the way that it's intended to be used. And if necessary, make changes in the design and so on. So it's part of the development process, and as a result, it is not underlying, not part of your final V& V, your final verification and validation testing. And because of that, John, one could easily argue that, does FDA have any business, any statutory authority, to regulate formative usability testing? Believe me, they try. And in many cases, they do. But it's not part of your final V& V. So should they regulate it? I'll leave that as a rhetorical discussion. The second phase of usability testing, as you pointed out, is what we call summative testing. This is the testing that occurs after the point of design freeze. The purpose of summative testing is not to provide feedback to the engineers, because you're already at the point of design freeze, the purpose of the summative testing is to ensure that your product can, in fact, be used the way it's... to support your label claims, to be used safely and effectively, yada, yada, yada. Because it is part of your final V& V testing, it is subject to FDA regulation. No doubt about it. There are, in some cases, John, and I've got another one of my customers that's going to the FDA right now with a sprint, because we got a BDP on this particular device, to argue that summative testing is not necessary. That formative testing is sufficient for this particular device. Whether we're successful with that argument, obviously time will tell, I think maybe we have a 50/ 50 shot, I'm not sure. But bottom line, it's another example of how usability testing requirements should not be applied equally across the board to all medical devices, regardless of anything else. At least in my opinion, John.

Jon Speer: Yeah. I agree with you 100% there.

Mike Drues: Perhaps one other thing to dig into just a tiny bit further before we start to wrap this up, you mentioned risk. Obviously as our audience knows, risk is an important topic for both of us, so doing usability testing from a risk perspective is very important. But what kind of risk, John? So I hinted, at a moment ago, it's one thing to talk about when our device is used according to the label. In other words, the way that we hope, would like to believe that our device is used. But what about risks? And, for the sake of today's discussion, John, let's limit it to usability risks. What about usability risks that may be associated with our device when it is not used according to the label? Do you think that that's something that a company should be concerned about, John?

Jon Speer: Oh, 100%. As far as the terms formative and summative, not necessarily implying formality behind them, but just conceptually it makes a lot of sense. I mean, if I'm designing a medical device, yeah, I'm a smart person, I'm an engineer, I've got my degree. I'll go grab it for you, if you want. I can point to all medical devices that I have designed and developed over the years. But to your early point, not a clinician, not doctor, never performed any sort of surgical procedure or medical procedure in any way, shape, or form on anything that was alive or human. But who am I to presume that I know anything about the practice of medicine? Why wouldn't I want the user, the clinician, the doctor, whomever, why wouldn't I want them to inform the design of my product? At the end of the day, they're going to be using it. And why wouldn't I know, at the end of the day, that my product actually works? To me, these are risks that, if I don't do those sorts of things, I'm incurring risk. About whether the product is used correctly, incorrectly, whether or not the product works, doesn't work, and that sort of thing. So, absolutely, I need to be concerned about that.

Mike Drues: Best thing for usability, especially for off- label uses of our product is admittedly, John, a very, very fuzzy area, for a very long time. But I think it's going to even be more germane in the weeks and months to come. Why? Because, you may remember, John, I think it was actually our last podcast or maybe the podcast before that, where we talked about this new rule that FDA just finalized. What's called manufacturer's objective intent, which basically now gives FDA the statutory authority to ask for data to support the off- label use of a medical device. And we can provide, perhaps, a link to that podcast and the resources if the audience is interested. But that, from a usability perspective, John, now that does open the door for FDA to ask a manufacturer specifically for usability data. Including sumative usability data for off- label uses of the device. Whether or not FDA chooses to walk through that door, and if so, how far? Time will tell. But because of that finalization of that rule, which was just literally a few weeks ago, that does open that door. So I think that these issues are going to become more and more important to medical device manufacturers in the future.

Jon Speer: I agree. Totally agree, yeah. Mike, any final thoughts on the topic of human factors and usability before we wrap things up today?

Mike Drues: Well, in a nutshell, usability is an important topic for virtually all medical devices across the board. Although, as we talked about earlier, let me modify that slightly. I do think that usability should be considered. It should be one of our product development tick boxes, if you will, for all medical devices. I don't care what it is, but whether or not you actually do usability testing, and if you do, how much and so on, that should be up to the manufacturer. And that should be, then, taken to the FDA, sell it to them. I would like to think, John, that I worked in an industry where we wouldn't need the FDA or some other police entity to tell us to do things that we, as medical device professionals, should know to do. And I'm using... John, very seriously. If I call myself medical device professional or a medical device expert, to me, that means... And if you don't know the importance of usability in your particular medical device, with all due respect, my question to you is, why the heck do you have the job that you have? I'm not trying to be harsh. I'm not trying to be unkind. But it's just like, if you needed surgery, you would expect the surgeon to know what he or she is doing. And if they don't know what they're doing, they shouldn't be in the OR. Well, the same thing applies to us. If we're going to claim to be medical device professionals, experts, whatever word you use, we need to have that expertise. Or at the very least, we need to acknowledge that that's important. And if we don't have that expertise ourselves, then we need to get somebody like you or me or somebody in the room to help. None of us, myself included, can be an expert in everything. But what we have to understand is, what things that we're good at and what things that we're not. And things that we're not, we need to bring in those resources to help. Does that make sense, John? What would you add to the discussion?

Jon Speer: It does make sense. And I would encourage people, just think about the things, the products, the things that you use in your everyday life. For example, this coffee mug. What if I picked it up and the handle fell off? That would suck. Did the person that designed, this or manufacture that, is that what they intended to happen?

Mike Drues: But is that a usability question, John, if the handle falls off?

Jon Speer: Well, it could be. Or what if my ink pen, I push the button and it doesn't write or whatever the case may be. It doesn't work the way I expect it.

Mike Drues: I was just going to add, to use your cup metaphor, because I love that simple example. If your hand did not fit into the handle, that would clearly be a usability issue. But if the handle falls off, maybe because it's a weak bond or it's not mechanically strong enough or whatever, I'm not sure if that's a usability issue. I think that might be more of a design or possibly a manufacturing or a materials issue.

Jon Speer: Fair enough. But the moment you pour hot liquid in this and the material melted, that would be a problem. But nonetheless, I mean think about all the products we, as humans, use in our all day, everyday life. And we expect them to work. Sometimes there are products we use then don't work, and by and large, might be just fine. Maybe no harm, no foul. Maybe a little bit of a disappointment, maybe I wasted some money. Is that how you want your medical device to be viewed? Is, oh, no big deal. It failed.

Mike Drues: Good question. And the last important point that I would like to bring up for you and our audience to consider is, doing usability testing or not is sort of a binary, a yes or no question. But to me what's more important is, how are we doing that usability testing? In other words, how realistic is it? Because if it's not realistic, what's the point of doing it? And my favorite example, I may have shared this with you before, John, I happened to be doing a presentation at a conference, and coincidentally, the person presenting at the conference before me, she was talking about the usability study for their particular device. And this was a surgical device, I believe, and she mentioned that one of the exclusion criteria of being in the study was that the surgeon had to read and follow the DFU, the directions for use. And I wanted to have a public debate about this. I raised the question, well, you realize that you now have totally invalidated your entire usability study. Why? Because we know that the vast majority of people are not going to do that. The vast majority of people are going to take the DFU out of the box and throw it right into the trash. And she said," Yes, Mike, I agree 100%, but it passed muster to the FDA." So the question is, and you're laughing, John, but you appreciate my not so subtle use of humor. What good is doing any kind of a test, whether it's a usability study, whether it's a clinical trial, whatever, if it's not realistic of the real world? Something to think about.

Jon Speer: Yeah and I think that's a great thought to leave people with on this conversation. Mike, I had a great time. This was a good conversation. So thank you for sharing your insights. Folks, if you've listened to The Global Medical Device Podcast before, good chance you've heard Mike and I chat about a variety of topics. And if so, you've heard me say that Mike Drues with Vascular Sciences is the best regulatory resource that I've ever worked with and crossed paths with. And I would encourage you that, if you like creativity and regulatory, yes, those things can be used in the same thought and sentence, then Mike Drues is a guy you should reach out to. Don't just follow blindly just because so and so did this or that regulatory body is requiring it. Sometimes things need to be challenged and Mike is a guy that does that on a frequent basis. So reach out to him and be happy to connect. So thank you, Mike. And folks, as always, we appreciate you listening to The Global Medical Device Podcast. It's because of you and your loyal listening and sharing the word to your friends and colleagues that we remain the number one podcast in the medical device industries. So thank you so much for that. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to The Global Medical Device Podcast.

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